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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report date:
1982

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Tetrasodium ethylenediaminetetraacetate
EC Number:
200-573-9
EC Name:
Tetrasodium ethylenediaminetetraacetate
Cas Number:
64-02-8
Molecular formula:
C10H16N2O8.4Na
IUPAC Name:
tetrasodium 2,2',2'',2'''-(ethane-1,2-diyldinitrilo)tetraacetate
Test material form:
solid
Specific details on test material used for the study:
- Lot/batch No.: 03370
- Impurities (identity and concentrations): 8% Na3 Ethylenediaminetriacetic acid, 1.2% Na2 Ethylenediaminetriacetic acid, 3.6% Na3 Nitriloltriacetic acid, < 0.3% Na2 iminodiacetic acid, 2.6% Na-glycolic acid, urotropin
- Expiration date of the lot/batch: April 1984
- test material contained 1.64% NaOH

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Diet: Ovator Solikanin; 130 g/day
- Water: tap water ca 250 mL/day
- Acclimation period: at least 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 26
- Humidity (%): 30 - 70
- Air changes (per hr): 15 - 20
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
occlusive
Preparation of test site:
clipped
Vehicle:
water
Controls:
other: Untreated skin of the same animal
Amount / concentration applied:
- 0.5 g (80% in water)
Duration of treatment / exposure:
4 h
Observation period:
8 days
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2 .5 cm X 2 .5 cm

REMOVAL OF TEST SUBSTANCE
- Washing (if done): once with lutrol and once with lutrol/water 50%/50%
- Time after start of exposure: 4 h

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0.4
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
Additionally there was a slight erythema (grade 1) in all animals 30 - 60 min after removal of TS.
Other effects:
No other effects

Applicant's summary and conclusion

Interpretation of results:
other: CLP/GHS criteria not met; no classification required according to Regulation (EC) No. 1272/2008
Conclusions:
CLP: not classified